Sandoz Hiring in Regulatory Affairs

Major Accountabilities

1. Life Cycle Management of Marketing Authorizations (MAs):
   • Manage MAs throughout their life cycle, focusing on major markets like EU, US, Canada, Japan, Australia, Brazil, China.
2. New Submissions and Planning:
   • Plan and execute new submissions in Most of World (MoW) regions as per set targets.
3. MA Transfers:
   • Responsible for transferring MAs and maintaining product history within defined timelines and processes.
4. CMC Documentation:
   • Author and organize high-quality CMC documentation (dossiers) for health authority submissions, ensuring technical congruency, regulatory compliance, and meeting e-publishing requirements.
5. Variations Submissions:
   • Handle work-sharing and super grouping variations submissions.
6. CMC Responses:
   • Prepare CMC responses to health authority questions during development, registration, and throughout the product lifecycle.
7. Regulatory Evaluation:
   • Evaluate change controls and other quality events for regulatory impact, including administrative changes.

Minimum Requirements

• Experience in regulatory affairs, specifically in CMC documentation and submissions.
• Familiarity with international regulations, especially in major markets.
• Strong organizational skills and ability to manage multiple projects.
• Excellent communication skills and ability to work effectively in a team.

Application Link